The examining and approving agency shall give a written reply within one month of receiving the application.

审批机构应在接到申请书之日起一个月内予以批复。

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The operating term may be extended after expiration upon the approval of the examining and approving agency.

经营期满，经审批机构批准，可以延期。

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In case the said deadline is not prescribed in the agreement, the approving agency shall not approve the transfer.

协议中未规定有关期限的，审批机关不予批准。

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The agreement also bars Australia's patent agency from approving generic versions of a drug while a patent application is pending.

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It also represents the general sense of caution on the part of the agency when approving new drugs, and therefore is bad news for companies like Arena Pharmaceuticals, which is expecting an FDA decision on its weight-loss drug at the end of the week.

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The charges stunned the FDA. Mr. Liang works in the division in charge of approving new drugs, the agency's most visible and sensitive role.

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